Quantification of Viral Load in the Upper Respiratory Tract in Patients Treated With Olsetamivir for Influenza

NCT ID: NCT04515446

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-04

Study Completion Date

2026-03-10

Brief Summary

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Seasonal influenza is a frequent disorder with high impact on morbidity and mortality and significant burden on healthcare-related cost. In France, the 2018-2019 flu epidemic has led to 13,100 all-cause death including 9,900 death directly related to the viral infection.

As cross-transmission of influenza is responsible for nosocomial outbreaks, preventing transmission of infectious agents in healthcare settings is a major issue. If vaccination of patients and healthcare givers remains cornerstone, control procedures are mandatory. Therefore patients admitted with influenza require isolation precautions including admission in a single room and protective measures. Based on experts advise, isolation is currently recommended for 5 to 8 days. Duration of isolation depends on immune status and antiviral therapy. However, during periods of epidemic, every hospital room is valuable and each ressource has to be tightly used. Risk of contamination is related to the presence of influenza in the upper airways. To the Promoteur 's knowledge, presence of influenza in the upper airways has not been studied in patients receiving oseltamivir. The question is : Do duration of isolation in patients admitted with flu decreas when they are treated with antiviral therapy. To answer this question The Promoteur would aim to determine influenza carriage in the upper airways in in-patients treated by olsetamivir.

Detailed Description

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Conditions

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Flu

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Monocentric, prospective, transversal, diagnostic measurement, blind, descriptive study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TROD + PCR diagnosis

For each patient positive for flu with a rapid diagnostic test, sequential nasopharyngeal (NP) samples will be collected for quantitative PCR every day from D1 to D8 or until discharge (if before D8). Sequential quantitative PCR will quantify influenza virus load in the upper airways.

Group Type OTHER

Rapid test for diagnosis orientation

Intervention Type DIAGNOSTIC_TEST

Rapid tests screen for influenza viruses in less than 30 minutes. They detect internal viral nucleoproteins by immunochromatography using specific antibodies attached to one or more strips.

quantitative PCR

Intervention Type DIAGNOSTIC_TEST

Molecular biology method of gene amplification in vitro. It allows a large number of known DNA or RNA sequences to be duplicated

Interventions

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Rapid test for diagnosis orientation

Rapid tests screen for influenza viruses in less than 30 minutes. They detect internal viral nucleoproteins by immunochromatography using specific antibodies attached to one or more strips.

Intervention Type DIAGNOSTIC_TEST

quantitative PCR

Molecular biology method of gene amplification in vitro. It allows a large number of known DNA or RNA sequences to be duplicated

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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TROD

Eligibility Criteria

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Inclusion Criteria

* Adult patients (≥18 years)
* Positive testing for influenza (A or B)
* Patients hospitalized and treated with olsetamivir
* Signature of informed consent
* Affiliation to healthcare insurance (France, Monaco)

Exclusion Criteria

* Refusal to participate
* Admission to intensive care
* Palliative care
* Unable to give inform consent
* Patients under legal protection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Princesse Grace

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Princesse Grace

Monaco, Municipality of Monaco, Monaco

Site Status

Countries

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Monaco

References

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Li X, Zhang Z, Yu A, Ho SY, Carr MJ, Zheng W, Zhang Y, Zhu C, Lei F, Shi W. Global and local persistence of influenza A(H5N1) virus. Emerg Infect Dis. 2014 Aug;20(8):1287-95. doi: 10.3201/eid2008.130910.

Reference Type RESULT
PMID: 25061965 (View on PubMed)

Keeler SP, Dalton MS, Cressler AM, Berghaus RD, Stallknecht DE. Abiotic factors affecting the persistence of avian influenza virus in surface waters of waterfowl habitats. Appl Environ Microbiol. 2014 May;80(9):2910-7. doi: 10.1128/AEM.03790-13. Epub 2014 Feb 28.

Reference Type RESULT
PMID: 24584247 (View on PubMed)

Patterson Ross Z, Komadina N, Deng YM, Spirason N, Kelly HA, Sullivan SG, Barr IG, Holmes EC. Inter-Seasonal Influenza is Characterized by Extended Virus Transmission and Persistence. PLoS Pathog. 2015 Jun 24;11(6):e1004991. doi: 10.1371/journal.ppat.1004991. eCollection 2015 Jun.

Reference Type RESULT
PMID: 26107631 (View on PubMed)

Other Identifiers

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18-06

Identifier Type: -

Identifier Source: org_study_id

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